DIADYSAS: Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT03605329

Collaborator

(none)

Enrollment

Location

Arm

16.8

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Diabetes Mellitus, Type 1	Other: to explore the severity of NAC in case of OSAS	N/A

Detailed Description

Cardiovascular autonomic neuropathy (CAN) is a common complication of type 1 diabetes (T1D) and is associated with increased cardiovascular risk. Otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (OSAs) in T1D. Cardiac autonomic modulations are deeply altered in OSAS. The combination of T1D and OSAS could therefore increase the severity of CAN and worsen the cardiovascular prognosis.

The most common method used to explore CAN is the study of heart rate variability (HRV). HRV is a practical, non-invasive and reproducible measure of autonomic nervous system function. HRV abnormalities are a predictor of hypertension and increased mortality in T1D.

Th investigators therefore propose to explore the severity of NAC in case of OSAS associated with T1D, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies.

The patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years.

The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.

Furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and CAN. Biological oxidative stress assays will improve physiopathological knowledge between T1D, OSAS and CAN. Finally, a 24-hour monitoring of blood pressure will be performed.

An ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with CPAP in 15 patients with severe OSAS (AHI ≥30 / hour) having previously participated in the main study. Fifteen patients with IAH <30 / hour will also be reassessed at three months to assess the intra-individual variability of the HRV.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome

Actual Study Start Date :

Sep 5, 2018

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Type 1 diabetic patients with OSAS to explore the severity of NAC in case of OSAS	Other: to explore the severity of NAC in case of OSAS After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan. The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.

Arm

Intervention/Treatment

Other: Type 1 diabetic patients with OSAS

to explore the severity of NAC in case of OSAS

Other: to explore the severity of NAC in case of OSAS

After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan. The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.

Outcome Measures

Primary Outcome Measures

study of heart rate variability (HRV) [day 1]
heart rate variability (LF/HF ratio) in type 1 diabetic patients with sleep apnea syndrome (AHI>15/h) in comparison with T1D patients with AHI <15/hour.

Secondary Outcome Measures

Evaluation of the severity of CAN [day 1]
measurements of urinary levels of catecholamines
measurements of sweat gland dysfunction [day 1]
Sudoscan
Characterization of the sleep architecture of T1D patients [day 1]
overnight polysomnography
monitoring of blood pressure [day 1]
a 24-hour monitoring of blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Type 1 diabetes patients with a diabetes duration of at least 5 years
Age between 18 and 60 years old.

Exclusion criteria:

OSAS treated with CPAP
Chronic alcoholism
Neuromuscular disease
Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker
Pregant woman